Psychological Intervention and Physiotherapy With Medication Improves CRPS Patients Outcome

NCT02467556 | Completed Phase 4

• 1 other identifier: Helsinki University Hospital
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A ten week open label study intervention to evaluate the outcome for a psychological intervention combined with physiotherapy and medication with memantine-morphine in 10 CRPS patients.

Conditions

CRPS

Keywords

CRPS; intervention; multimodal

Outcome Measures

Primary Outcomes (1)

• Direction of change in patient reported CRPS symptom discriptors

  Reports of CRPS symptoms

  Three months

Secondary Outcomes (3)

• Direction of change in motor parameters

  Three months

• Direction of change in psychological parameters

  Three months

• Direction of change in quality of life

  Three months

Study Arms (1)

intervention

OTHER

Open label study with psychological intervention and physiotherapy intervention with medication of morphine, memantine for ten weeks (morphine 30mg tbl per day and memantine up to 40mg tbl per day if tolerated).

Drug: Morphine, memantine; Behavioral: Psychological intervention; Other: Physiotherapy intervention

Interventions

Morphine, memantine DRUG

Morphine up to 30 mg per day orally and memantine up to 40 mg per day orally if tolerated for 10 weeks.

Also known as: Depolan (morphine), Ebixa (memantine)

intervention

Psychological intervention BEHAVIORAL

To help patients shift perspective from pain and CRPS-symptoms, to increase body awareness, to create vivid imagenary, to increase the use of a CRPS hand with mindfulness exposure exercises, to increase flexibility in behavioral repertoire, to explore the fusion of emotions, automatic cognitions and learned responses and to help patients to integrate new skills in their lives.

intervention

Physiotherapy intervention OTHER

Graded motor imagenary with group and individual weekly sessions with daily practices at home.

intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CRPS type 1 for at least 6 months,
• pain NRS 4 or more

You may not qualify if:

• major psychiatric or neurological disease

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Central Hospital

Helsinki, HUS, 00029, Finland

Location

Related Publications (3)

• Bean DJ, Johnson MH, Kydd RR. The outcome of complex regional pain syndrome type 1: a systematic review. J Pain. 2014 Jul;15(7):677-90. doi: 10.1016/j.jpain.2014.01.500. Epub 2014 Feb 12.

  PMID: 24530407 BACKGROUND

• Gustin SM, Schwarz A, Birbaumer N, Sines N, Schmidt AC, Veit R, Larbig W, Flor H, Lotze M. NMDA-receptor antagonist and morphine decrease CRPS-pain and cerebral pain representation. Pain. 2010 Oct;151(1):69-76. doi: 10.1016/j.pain.2010.06.022. Epub 2010 Jul 13.

  PMID: 20630656 BACKGROUND

• Elomaa M, Hotta J, de C Williams AC, Forss N, Ayrapaa A, Kalso E, Harno H. Symptom reduction and improved function in chronic CRPS type 1 after 12-week integrated, interdisciplinary therapy. Scand J Pain. 2019 Apr 24;19(2):257-270. doi: 10.1515/sjpain-2018-0098.

  PMID: 30789827 DERIVED

MeSH Terms

Interventions

Morphine; Memantine; Psychosocial Intervention

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Eija Kalso, MD, PhD

  Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 10, 2015
• Study Start: March 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 24, 2020

Record last verified: 2015-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)